Recently GlaxoSmithKline has decided to stop the manufacturing of their anti-seizure medication Potiga (ezogabine).
Medications are discontinued and taken off the market for a variety of reasons. Sometimes there are issues with safety, but sometimes a manufacturer will decide to discontinue a drug just because it’s no longer profitable. For example, this sometimes happens with brand name drugs that have a generic alternative—fewer and fewer people fill the more expensive brand over time.
Can a discontinued drug become available again?
Keep in mind that a discontinuation is different from a shortage. Shortages can be due to manufacturing issues, quality problems, delays anywhere along the manufacturing or shipping process—or by discontinuations. How does that work? Imagine there are two companies making a generic medication. One discontinues their generic version, and the other company now has to deal with a greater demand for a smaller supply. Shortages can be resolved, while discontinuations are permanent; a new application must be made to the FDA if a company wants to start making a discontinued drug.
What’s the process for discontinuing a medication?
It’s required that manufacturers alert the FDA if they intend to permanently discontinue a medication at least 6 months in advance, or as soon as possible.
What was Potiga used for?
Potiga was approved for use in combination with other anti-seizure drugs to treat partial-onset seizures in adult patients who have had an inadequate response to several alternative therapies and for whom the benefits of treatment outweigh the risks.
Why was Potiga discontinued?
GlaxoSmithKline has decided to discontinue Potiga due to very limited use and declining numbers of patients new patients starting the drug.
When was Potiga initially approved by the FDA?
Potiga was approved by the FDA in 2011.
When will Potiga no longer be available?
Potiga is no longer be available as of June 30, 2017.
Other than limited use, were there any issues with Potiga while it was on the market?
Yes. On April 26, 2013, just two years after the approval of Potiga, the FDA issued a drug safety communication stating that Potiga was causing skin discoloration and eye problems.
The FDA investigated these issues and on October 31, 2013, they approved label changes to include the most serious type of warning, a black box warning, alerting patients and prescribers that Potiga could cause potential vision loss and skin discoloration, which may be permanent.
On June 5, 2015, the FDA announced that it would require GlaxoSmithKline to conduct a long-term study to further explore any potential long-term consequences.
Is Potiga available in any other countries?
It was, but isn’t any longer. Until June 2017, Potiga was on the market in Europe under the name Trobalt, but it’s also been discontinued there.
Tinnitus, or ringing in the ears, is a perception of sound in one or both ears in the absence of an external source. It’s often described by patients as buzzing, ringing, or whooshing.
Tinnitus can be a continuous sound or occur intermittently and while there is often no known cause, there are a handful of medications that can contribute. “Ototoxic medications” are those that may damage the inner ear. Toxic damage to the ear from medications can result in symptoms like tinnitus, vertigo, and even deafness. Discontinuing these medications can prevent progression to hearing loss and/or vertigo, though the ringing may not always go away. Here are eleven commonly prescribed medications known to cause tinnitus:
- Gentamicin and tobramycin are aminoglycoside antibiotics used for the treatment of severe bacterial infections. Gentamicin, used intravenously, is a well known cause of tinnitus and vertigo along with hearing loss.
- Aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen (Aleve) and ibuprofen (Motrin, Advil) are well known causes of ringing in the ears. Those taking daily aspirin for stroke and heart disease protection should be given a heads up about this possibility—though tinnitus from aspirin usually occurs only at high doses.
- Loop diuretics including furosemide (Lasix) and bumetanide (Bumex) are commonly prescribed for swelling in the legs, heart failure, and to lower blood pressure. They are known to cause ringing in the ears.
- Tricyclic antidepressants like amitriptyline and nortriptyline are used for the treatment of depression, chronic pain, and migraine prevention and they may also cause ringing in the ears.
- Azithromycin (Zithromax or the “Z-pack”) and clarithromycin are antibiotics in a class called macrolides, and they’re prescribed for bacterial infections like community-acquired pneumonia, sinusitis, bronchitis, etc. Both are reported causes of ringing in the ears.
- ACE inhibitors are medications used to lower blood pressure that may cause ringing in the ears. These end in -il (common examples are lisinopril, enalapril, and ramipril).
- Amlodipine (Norvasc) and nicardipine (rarely prescribed) are calcium channel blockers. Amlodipine is commonly prescribed for high blood pressure, and reports of tinnitus follow its use.
- Alprazolam (Xanax), diazepam (Valium) and lorazepam (Ativan) are benzodiazepines used for the treatment of anxiety, which may cause tinnitus.
- Isotretinoin (Accutane, Claravis, Absorica, and others) is a pill used for severe acne that may lead to tinnitus.
- The fluoroquinolone antibiotic ciprofloxacin (Cipro) has been reported to cause tinnitus, but, some good news—those reports have not carried over to a similar antibiotic levofloxacin (Levaquin). Cipro is prescribed for bacterial infections like urinary tract infections, acute sinusitis and pneumonia and may lead to tinnitus.
- Atorvastatin (Lipitor), but not other statins, has been reported to cause tinnitus. Atorvastatin is used to lower cholesterol.
Thanks to the FDA’s Priority Review program, hepatitis C medications are being approved at a faster rate! This program provides a fast-track review of medications that could that treat serious conditions like hepatitis C. New approvals over the past few years include Sovaldi, Harvoni, Viekira Pak, and we have another one to add to the list!
On July 18th, 2017, the FDA approved Vosevi, a new three drug combination medication for Hepatitis C. Vosevi is the first and only hepatitis C treatment specifically for patients who have tried advanced treatment and haven’t been cured.
What is Vosevi prescribed for?
Vosevi is a combination medication indicated for the treatment of chronic hepatitis C in adults, and is a second line treatment for all 6 types of hepatitis C genotypes.
It will be available as a combination tablet in the strength of 400 mg/100 mg/100 mg. The recommended dose is one tablet, every day with food, for twelve weeks.
What are the most common side effects associated with Vosevi?
Common side effects include headache, fatigue, diarrhea, and nausea. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
Will Vosevi be a specialty medication?
Not sure. At this time there is no information stating that Vosevi will be considered a specialty medication; however, with all of the other Hepatitis C medications being specialty medications Vosevi will likely follow suit.
How much will Vosevi cost?
Gilead, the manufacturer, has not mentioned how much Vosevi will cost.
Epclusa, another hepatitis C medication manufactured by Gilead, is priced at $74,760 for a 12-week regimen. The cost of other 12-week hepatitis C medication regimens currently on the market such as Sovaldi and Harvoni cost $84,000 and $94,500 respectively. Therefore, it is expected that Vosevi will be priced right in line with the cost of these other treatments.
Gilead does offer a copay assistance program where eligible patients can pay as little as $5 per co-pay for Vosevi. To find out if you qualify, call 1-855-769-7284 to speak with a Vosevi Support Path specialist.
Doctors are often asked what ONE pill or supplement they would recommend, or take themselves. The answer to this, I have learned, depends on perspective—based on which specialty the physician practices. So, after 20 years of being surrounded doctors in many fields at an academic medical center, here is the one pill you should be taking, by specialty.
Aspirin, but not for everyone. Studies of aspirin for primary prevention of heart disease suggest about a 22% reduction in risk for non-fatal heart attack. Because aspirin increases the risk of gastrointestinal bleeding it’s not for everyone. The greatest benefit is seen in adults ages 50 to 59 with moderate to high cardiovascular risk, and those with risk factors like high blood pressure, high cholesterol, diabetes, family history of early heart disease, etc.
Runner up for this answer from a cardiologist would be a statin drug. Large clinical trials have shown statin therapy (atorvastatin, simvastatin, rosuvastatin) to be effective and safe for prevention of atherosclerotic cardiovascular disease (clogged arteries). Again, this holds true for adults ages 40 to 75 years, and in those who are eligible based on 10 year risk calculators—NOT everyone.
Gastroenterologist (“GI” Doctor)
Probiotics. Whether you struggle with lactose intolerance, irritable bowel syndrome, traveller’s diarrhea, Clostridium difficile (C. diff) diarrhea, or mild colitis symptoms, your GI doc will likely recommend probiotics in the form of fermented milk products (yogurt, kefir) or probiotic capsules (VSL #3, Align). Start with active culture yogurts or kefirs, but if you can’t tolerate dairy and need a supplement, look for one that contains multiple species (Lactobacillus, Bifidobacterium, etc) with high colony counts.
Runner up. For GI doctors who treat colon cancer patients, a daily aspirin may be recommended for the prevention of colon cancer. Two recent large studies have shown that the use of aspirin for 6 years or longer led to a 19% decreased risk of colorectal cancer and a 15% decreased risk of any type of gastrointestinal cancer. Again, given some of the risks associated with a daily aspirin, this isn’t for everyone.
Aspirin, but again, not for everyone. Stroke kills 133,000 Americans a year. For moderate and high-risk patients, studies of aspirin for prevention of stroke show it lowers your risk by approximately 14%. That’s pretty good given that aspirin costs pennies a day.
Runner up here would be a recommendation by neurologists who treat headache patients to try the supplements riboflavin 200 mg/day, magnesium 200 mg/day and CoQ10 75 mg/day which are available together as one supplement in Migrelief, Dolovent, or Migravent. The American Academy of Neurology recommends vitamin B2 (riboflavin), magnesium, and coenzyme Q10 for migraine prevention as alternatives to prescription drugs, given the desire for more natural treatment options and evidence that this supplement may reduce the number of headache days per month.
Ophthalmologist (Eye Doctor)
AREDS 2 vitamin. Taken once daily in those with intermediate to severe macular degeneration, the most common cause of blindness in the United States, an AREDS 2 combo vitamin available over the counter reduces the risk of progression of macular degeneration by as much as 19 percent, and of vision loss by 25 percent. Say what?! The AREDS 2 supplement is one of the only available treatments proven to be effective for intermediate-to-severe dry macular degeneration. What’s in AREDS 2? Lutein, zeaxanthin, vitamins E and C, zinc, and copper.
Skin doctors will say, in answer to the ONE thing their patients should be taking, a vitamin D capsule. Why? Because your dermatologist does not want you in the sun. Instead, they want you to get adequate vitamin D through a supplement (maintenance dose of approximately 2000 IU per day). Skin cancer is by far the most common type of cancer in adults and sun exposure is your major risk factor. They don’t want you to get that.
Vitamin D, again, but only in those with low vitamin D levels (hypovitaminosis D). Low vitamin D is associated with more severe osteoporotic hip fractures, and vertebral/spine fractures. Simply put, your orthopedic doctor wants you to have normal vitamin D levels, and to take vitamin D supplements to normalize them if you don’t.
Runner up would be a glucosamine plus chondroitin supplement in folks with knee osteoarthritis, though there have been conflicting results about whether or not they work.
A daily folic acid supplement for the prevention of neural tube defects is recommended for all women planning pregnancy or capable of becoming pregnant. The body of evidence from randomized trials and large studies supports a folic acid supplement of 0.4 mg taken once a day to decrease the occurrence of neural tube defects.
Metformin, and not only for the treatment of diabetes. Metformin in prediabetics helps prevent the onset of diabetes, improves weight loss, regulates ovulation in patients with polycystic ovary syndrome (PCOS), and may help you live longer. Not kidding. Animal studies (and ongoing studies in humans) have focused on metformin to reverse aging since it may influence fundamental aging factors that underlie multiple age-related conditions. Metformin 1000 mg a day is commonly embraced by endocrinologists and internists for those reasons.
Vaginal estrogens. For postmenopausal women with recurrent urinary tract infections, urinary incontinence, or atrophy, most urologists and urogynecologists will advise starting on a vaginal estrogen (Estrace cream, Premarin cream, or Vagifem tablets). Excluded from this advice will be women with a history of estrogen-receptor-positive breast cancer.
A helmet. It’s not a supplement, but a pediatricians mantra is: wear a helmet, wear your seatbelt, don’t ride a motorcycle, and don’t smoke. Unintentional injuries are the number one cause of death in the pediatric population and a helmet is your one thing in this case . . . not a pill or a supplement.
What did I miss?
Evidence from a large study in New Zealand for bacterial meningitis revealed an interesting finding – the meningitis B vaccine may help protect against gonorrhea. These findings are just observational though, and extensive clinical trials will need to be performed to ensure the effectiveness and safety of the vaccine.
Gonorrhea is a sexually transmitted infection caused by unprotected vaginal, anal or oral sex. It can be cured if properly treated, however, gonorrhea can cause complications like infertility, sepsis or arthritis if not treated.
On July 7th of this year, the World Health Organization (WHO) issued a news release that antibiotic-resistant gonorrhea is on the rise. With this resistance developing, it is expected that pharmaceutical companies will begin to explore forms of treatment such as vaccinations. Unfortunately, the vaccine that showed positive results for gonorrhea, MeNZB, is no longer available in the UK and has never been used in the United States.
It is too early to make assumptions about the use of the meningitis B vaccine, but this could be a step in the right direction towards preventing gonorrhea, especially amidst the emergence of bacterial resistance.
What is meningitis?
Meningitis is a life threatening infection that can cause inflammation of the brain and spinal cord membranes. Symptoms usually arise one week after exposure to the bacteria and include muscle pain, fever, lethargy, loss of appetite, nausea or vomiting. Currently, in the United States, there are three common forms of meningitis – B, Y, and C.
How can I protect myself against gonorrhea?
For now, the most effective way to prevent gonorrhea is to always use a condom during sex, even during oral or anal sex.
Are there any vaccinations available for sexually transmitted infections?
Yes. HPV is the most common sexually transmitted infection in the United States. The HPV vaccine can protect against disease (including cancer) caused by HPV, when given at the appropriate time. You can read more about the HPV vaccine, Gardasil, here.